August 2021 FDA Recall Drug by Teligent Pharma, Inc.
D-0800-2021 - Superpotent Drug

This Class I drug recall was voluntarily initiated by Teligent Pharma, Inc. on August 3, 2021 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0800-2021

Reason for Recall
Superpotent Drug
Initiated
08-03-2021
Reported
09-22-2021
Quantity
32,544 glass bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88454
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teligent Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States and Canada
Product Description About Product Description
Full technical description of the product.
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

Batch or Lot Expiration Information

Lot# :14218, Exp. Date 08/2022